Catalog Number

-

Brand Name

coDiagnostiX

Version/Model Number

9

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2021

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130724,K130724,K130724,K130724

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

68940839-990a-46e5-a579-b51ab3683d2a

Public Version Date

August 31, 2021

Public Version Number

7

DI Record Publish Date

September 17, 2016

Package DI Number

D835CDX202

Quantity per Package

40

Contains DI Package

D835CDX1

Package Discontinue Date

August 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-